Formulations of a SRC/ABL inhibitor

Abstract

The invention relates to pharmaceutical compositions of ′N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, and to methods of using the pharmaceutical compositions in the treatment of oncological and immunological disorders

1 . A pharmaceutical composition for oral administration comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a compound of formula (I) solvate, hydrate, or pharmaceutically acceptable salt thereof  
     
       
         
         
             
             
         
       
     
     and a non-reactive coating.  
   
   
       2 . The composition of  claim 1  wherein the non-reactive coating does not react with the compound of formula (I).  
   
   
       3 . The composition of  claim 2 , wherein the non-reactive coating is a coating having polyethylene glycol as plasticizer.  
   
   
       4 . The composition of  claim 3 , wherein the pharmaceutically acceptable carrier comprises lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.  
   
   
       5 . The composition of  claim 4 , wherein the microcrystalline cellulose is present in both intragranular and extragranular phase.  
   
   
       6 . The composition of  claim 4 , wherein about 15% by weight of the microcrystalline cellulose is in extragranular phase.  
   
   
       7 . A pharmaceutical composition for oral administration comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a compound of formula (I)  
     
       
         
         
             
             
         
       
     
     solvate, hydrate, or pharmaceutically acceptable salt thereof, 
 wherein the pharmaceutically acceptable carrier comprises intragranular and extragranular microcrystalline cellulose.  
 
   
   
       8 . The pharmaceutical composition of  claim 7 , wherein the extragranular microcrystalline cellulose is about 10-20% by weight.  
   
   
       9 . The pharmaceutical composition of  claim 8 , wherein the extragranular microcrystalline cellulose is about 15% by weight.  
   
   
       10 . The pharmaceutical composition of  claim 9 , wherein the composition further comprises a non-reactive coating.  
   
   
       11 . The pharmaceutical composition of  claim 10 , wherein the non-reactive coating is a coating having polyethylene glycol as plasticizer.  
   
   
       12 . A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a compound of formula (I)  
     
       
         
         
             
             
         
       
     
     solvate, hydrate, or pharmaceutically acceptable salt thereof, wherein the compound of formula (I) has a particle size of less than or equal to about 150 microns and the pharmaceutically acceptable carrier comprises intragranular and extragranular microcrystalline cellulose.  
   
   
       13 . The pharmaceutical composition of  claim 12 , wherein the particle size of the compound of formula (I) is less than or equal to about 130 microns.